Omega-3 supplements for children and teens with autism
Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD
Over 12 weeks this study will see if omega-3 supplements help children and adolescents (ages 6–17) with autism by comparing omega-3 to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung, Taichung) |
| Trial ID | NCT07365553 on ClinicalTrials.gov |
What this trial studies
This is a 12-week interventional study enrolling children and adolescents aged 6–17 with a DSM-5 diagnosis of autism spectrum disorder. Participants will receive either omega-3 polyunsaturated fatty acids or a matching placebo and will be followed with scheduled visits. The primary outcome is change in clinical symptoms measured by the Aberrant Behavior Checklist (ABC); secondary outcomes include inflammatory biomarkers, cognitive testing, and physiological measures such as heart-rate variability. Key eligibility criteria exclude current omega-3 use and major psychiatric or physical comorbidities, and all visits occur at China Medical University Hospital in Taichung.
Who should consider this trial
Good fit: Children and adolescents aged 6–17 with a DSM‑5 diagnosis of ASD who are not currently taking omega‑3 supplements, have had no recent medication or therapy changes, and do not have major psychiatric or physical comorbidities.
Not a fit: Patients with comorbid major psychiatric disorders (such as bipolar disorder, major depressive disorder, schizophrenia), significant physical illnesses, current omega‑3 use, or an allergy to omega‑3 are excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, omega-3 supplementation could modestly reduce behavioral symptoms and inflammation, offering a low-risk adjunct treatment for youth with ASD.
How similar studies have performed: Previous small trials of omega‑3 in ASD have produced mixed and generally modest results, so the approach is plausible but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of DSM5 ASD made by child and adolescent psychiatrist * age 6-17 years-old at the time of enrolment * no pharmacotherapy or non-pharmacotherapy adjustment within the past 4 weeks, * Signed informed consent. Exclusion Criteria: * comorbid other psychiatric disorders, including schizophrenia or affective mood disorder (Bipolar and Major Depressive Disorder), or substance use disorder * comorbid physical disorders, such as thyroid dysfunction, cerebral palsy, coagulation disorders * currently using omega-3 supplements or probiotics * allergy to omega-3.
Where this trial is running
Taichung, Taichung
- China Medical University — Taichung, Taichung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Pei-Chen Chang, MD, PhD — China Medical University Hospital
- Study coordinator: Pei-Chen Chang, MD, PhD
- Email: d13121@mail.cmuh.org.tw
- Phone: 0422052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.